Disclaimer:
This
A Newsletter Published by the Members of conférence bleue
December 2007 / Issue 18
To view an article, please click on title.
Finland
Preparing Adoption of Reference Price Model
Sweden -
Deregulation of Retail Trade in Medicines
conférence bleue, the European
Lawyer’s Conference on Pharmaceutical and Health Care Affairs is
celebrating its 10 year anniversary. The
lawyers’ network was established in November 1998. The network has reached an impressive size with
20 European law firms. . Combined, the members also
have a worldwide presents with over 103 international offices.
Important clients as well as numerous high ranking officials
of the European Commission were invited to attend and speak at the pharmaceutical
seminar held in
The day prior to the seminar the Board and
General meetings took place. Prof. Dr. jur. Dr. med. Alexander P. F. Ehlers of
the Law firm Ehlers Ehlers & Partner,
The meetings adopted the resolution to continue to acquire
new members in Central and
For more information and press photos please contact:
Kathleen M. Dwyer
conférence bleue
Managing Director
Weilbachweg 17
82541 Münsing
Tel.: +49-8177-997481
Fax: +49-8177-997482
Email: conf.bleue@t-online.de
Finland allowed generic substitution on 1
April 2003. Based on the current system, substitutable medicinal products are
listed by the National Agency for Medicines and grouped by indication, active
substances, and strength. The list is renewed quarterly. Actual substitution is
carried out by retail pharmacies where the pharmacy must inform the patient of
the possibility to dispend the prescribed medicine to the lowest cost product
or to one that differs only slightly in price from the lowest cost product
(i.e., EUR 1.99 or EUR 2.99). In addition to the substitutability of the
product and the patient’s consent, substitution further requires that the
prescribing physician has not expressly forbidden it. A patient’s refusal
to allow substitution does not effect reimbursement of the medicinal product,
which may be 100% (with a deduction of 3 euros), 72%, or 42% of the retail
price of the product the patient decides to purchase.
Despite the cut in medicine-related expenses
that generic substitution has created so far, further savings have been deemed
necessary. In order to find a solution, a working group was established to
study the effectiveness of reference price systems in relation to medicine
reimbursement costs. The working group reviewed the reference price models used
in other EU member states, and. generic models with
different aspects were evaluated. Also, the possibility of a therapeutic model,
where the products would be grouped depending on their therapeutic equality,
was discussed.
The working group’s conclusions in
June 2007 were that a generic reference price model could be fit into the
Finnish system, and that it could be introduced in the beginning of 2009. The
working group’s conclusions regarding the therapeutic model were that its
introduction would require further consideration. The working group did not as
such give any recommendations as to which reference price model would be
preferable, as the question is political in nature. It has been assumed based
on statistics that the reference price system would apply to approximately
2,500 different packages, i.e., 30% of all packages in sale. It can be assumed
that the effect on the medicine business will be substantial.
In light of the working group’s
conclusions and the political views adopted in the wake of those conclusions,
it seems clear that a generic reference price model will be adopted. In recent
discussions, a generic model where the reference price would be determined
based on the lowest price on the market has been abandoned. Consequently, it
seems that a system in which either 50 cents or some euros is added to the
lowest price on the market to form the reference price will prevail. The exact
model will be included in the Government’s proposal, which is expected to
be given in the beginning of 2008, and the change will most likely take effect
in 2009.
Since Law Nr 2125 of
This law was contested
along the years the
In 2006 the Portuguese
Competition Board considered that Law Nr 2125 was against free competition and
issued an advice in the sense that the ownership of pharmacies should be
liberalised.
Decree-Law Nr 307 of 31 st
August 2007 approved the ownership of pharmacies further to Law Nr 20 of 12 th
June that allowed the Government to legislate about the matter. Nr 1 of art.14
of this Decree-Law defines that individuals or corporations may be owners of
pharmacies. However according to art.15 no individual or company may own more
than four pharmacies.
In the sense of pursuing
the liberalisation of the pharmacy activity, Minister's decision 1427 of 2 nd
November 2007 allowed that medicines be prescribed through the internet.
Minister's decision Nr 1428
of the same date defines the communication regime between pharmacies and the
Portuguese Medicines Regulatory Entity, Infarmed.
Minister's decision Nr
1429/2007 also of 2 nd November 2007 states the pharmaceutical services that may
be rendered by pharmacies.
According to this decision
doctors who prescribe, associations representing pharmacies, companies that
distribute medicines in bulk, the pharma industry companies, companies that
render health services and similar ones may not own pharmacies. It is also
stated that pharmacies may not be sold or rented before five years elapse after
their opening. It changes to 3.500 people the number of people per pharmacy
that was 4.000 in the terms of the previous law. Accordingly the present law
opens the field for the opening of 350 more pharmacies. A public bid will be
launched with this purpose and a licence will be issued by Infarmed for each
new pharmacy to be opened.
According to the World
Health Organisation (WHO), sales of counterfeit drugs could reach more than US$
75 billion globally by 2010. The causes of the rapid growth of pharmaceutical
counterfeiting in recent years include weak national and international
legislation, the high profitability and low risk of manufacturing fake
medicines, the development of the internet and wider access to technology.
In
In September 2006 the
European Parliament adopted a resolution on counterfeiting of medicinal
products which called on
The study on counterfeit
medicines launched by DG Enterprise and Industry will also address track and
trace aspects of the issue, including RFID tagging. The Commission held public
consultations on RFID in 2006 and issued a Communication in March 2007 entitled
"An effective, safe, secure and privacy-preserving approach to RFID".1 Both the Commission and the
pharmaceutical industry consider RFID technology has great potential to
increase the quality of care and patient safety and improve compliance with EU
law and logistics in the supply chain, and that its use in hospitals and
healthcare should be explored. In July 2007 the Commission ordered a more
specific "Study on the requirements and options for actions in RFID in
healthcare", which aims to improve understanding of the potential risks of
using RFID and its potential for improving distribution of pharmaceuticals in
the EU. Based on this study, the Commission will make new proposals for
large-scale, effective and secure implementation of RFID in EU healthcare
systems. The EU is already investing in RFID through research projects
co-funded by the Commission (e.g. the BRIDGE project).
Most decision-makers
consider that track and trace should be seen as part of an integrated approach
to fighting counterfeit medicines, which should also include better access to
medicines in poor countries, adoption of criminal penalties2
and a possible ban or restrictions on repackaging by parallel traders. In
addition, the introduction of strict liability for counterfeit products for all
participants in the increasingly complicated European distribution system
(parallel traders, repackagers, pharmacists, etc.) would set the right
incentives to minimise the chances of counterfeit products entering the supply
chain.
Parallel trade is among the
most common infiltration points for counterfeit products in the legitimate
supply chain (see the recent cases of counterfeit Zyprexa3
and Casodex4 in the
Implementing a European
system for the identification and coding of medicines would entail harmonising
national identification systems. A legal basis for a European track and trace
system already exists in Directive 2001/83/EC, the Community code relating to
medicinal products for human use,5
which allows Member States to require specific forms of labelling for
identification and authentication purposes. Article 57 of Directive 2001/83
reads: "Notwithstanding Article 60,
Member States may require the use of certain forms of labelling of the
medicinal products making it possible to ascertain : the price of the medicinal
product; the reimbursement conditions of social security organisations; the
legal status for supply to the patient, in accordance with Title VI;
identification and authenticity."6
A system which would enable pharmaceutical companies, pharmacists,
pharmaceutical agencies and national reimbursement authorities to ensure
improved safety for patients through the use of a barcode system clearly falls
within the last category listed in this Article. Article 65 of the Directive
would allow the Commission to coordinate national efforts by drawing up
guidelines on methods for identifying and authenticating medicinal products and
harmonised provisions for the implementation of Article 57.
The Commission needs to act quickly and efficiently to avoid the risks and
implications of many different and potentially incompatible national track and
trace systems, which would completely undermine the single market in
pharmaceuticals. The European Medicines Agency (EMEA) could play a leading role
in implementing a European coordinated effort to adopt common technological
standards. There are also strong arguments for coordinating the EU’s
approach with US efforts to fight counterfeiting. Having two completely
different standards for the tracking and tracing for the two biggest markets would
pose considerable logistical problems and impose a substantial financial burden
on all parts of the distribution chain.
The legal institution of
the rebate agreements was established 2003 with the Beitragsstärkungsgesetz to give the statutory health
insurers the option to negotiate with the pharmaceutical industry the terms of
an agreement for a discount of the pharmaceuticals provide for their insured
persons. The intention was to reduce costs in the sector of prescription-only
medicine by opening the pharmaceutical market to more negotiating partners and
to replace partially the reference price system. In a recent decision, dated as
of
In contrast, the Oberlandesgericht (hereafter referred to
as Higher Regional Court) Karlsruhe decided in a procedure opened by the Allgemeine Ortskrankankasse (Local Health
Care Fund) that all legal questions relating to the rebate agreements have to
be submitted exclusively to the Social Court. This is reasoned by the
The final decision has to
be awaited. If a Europe-wide tendering procedure for the rebate agreements has
to be conducted the options for the European pharmaceutical manufacturers might
increase to enter the financially strong German drug market (expenses for
pharmaceuticals in 2006 about 25 billions Euros), but this also implicates new
legal questions regarding marketing approval and drug registration according to
the German law.
Retail trade of medicines
in
The Swedish Government has
at the end of 2006 appointed an expert to analyse how the Swedish retail
monopoly in medicines can be dismantled in two steps.
As a first step, and not
later than
Even when the monopoly is
dismantled, Apoteket, if kept intact, by virtue of its very strong trademark
and its extensive organisation of course has a market position which makes it
very difficult and costly for potential competitors to challenge. Apart from
physi-cal resources, the necessary investments for instance in IT systems to be
able to provide even a basic service would be very expensive. It has, thus, for
example been suggested that the Apoteket pharmacies would be divided in 5-6
different clusters to be auctioned off in connection with the deregulation of
the monopoly.
Criticism has also been
raised against Apoteket since it is viewed that Apoteket is trying to impede
(and strengthen its own market position in advance of) the expected
deregulation of the monopoly. The criticism among other things relates to
Apoteket’s discussions with the largest
The deregulation is, on the
other hand, already underway with respect to anti-smoking aids where the
Government submitted a Bill on
With the approval of the
Royal Decree 1345/2007, of October 11, the transposition of Directives
2004/27/EC7 and 2004/24/EC8 into the Spanish legal system has,
if with unjustifiable delay9,
been completed. This Royal Decree, which abrogates the previous Royal Decree
767/1993, is intended to improve the operation of the procedures for
authorization of medicinal products by regulating in a single text the label and
the data sheet, reviewing the national and mutual recognition procedures, and
including the decentralized procedure, which enables to obtain, through a
single procedure, the authorization for commercialization in different Member
States.
One of the more
controversial issues in connection with the handling of medicinal product
dossiers has been the access to them by third parties, which is particularly
relevant with respect to the approval of generic medicines. The new regulation,
in line with the Community Directive, makes possible the access by the public
to the evaluation reports, after the confidential commercial information has
been deleted, to the authorization or refusal resolutions and to the
amendments, suspensions or revocations thereof. However, it is necessary to see
the evolution of the Administration practice before determining whether the
transparency principle is a mere formal right void of contents or if, on the
contrary, it will facilitate the exercise of the lawful rights of third parties
affected by the granting of the authorization for commercialization.
Another important novelty
is the unified regulation of all the special medicines which up to now had
their own legislation (radiopharmaceuticals, human blood and plasma
derivatives, immunological and homeopathic products and medicinal gases). This
unification has resulted in the regulation of determined subjects being rather
general, there being some gaps which should be supplemented with the
appropriate regulatory development, such as in the case of individualized
vaccines or in the extemporaneous preparation of radiopharmaceuticals. On the
other hand, and still in the field of special medicinal products, it should be
pointed out that next to traditional herbal medicinal products, there is
implicitly admitted the possibility of commercializing traditional medicinal
products on the basis of plants under food regulations provided that no
reference is made to therapeutic properties.
Finally, it seems that this
Royal Decree will permit the advertising to the public of a greater number of
medicinal products not subject to financing, even when some interpretation
issues have not been resolved yet, such as the possibility of advertising
medicinal products without prescription which require a diagnosis for
determined pathologies.
JAUSAS
For further information on this issue, please contact hjausas@jausaslegal.com
or mcedo@jausaslegal.com.
Disclaimer:
This
If you would prefer
not to receive this type of information, please send an email to conf.bleue@t-online.de . Your details
will then be removed from our mailing list.
Imprint:
conférence bleue
Headquarters; Widenmayerstrasse 29, D-80538 Munich | Administrative / Postal
Address: Weilbachweg 17, D-82541 Muensing
Email: conf.bleue@t-online.de
| URL: www.conference-bleue.com
Tel. +49 8177 997481 | Fax: +49 8177 997482